Regulations, 2003

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,433, 24 ta’ :unju, 2003

L.N. 136 of 2003

PRODUCT SAFETY ACT

(ACT NO. V OF 2001)

Method for Designating Conformity Assessment Bodies

Regulations, 2003

IN exercise of the powers conferred by articles 38 to 40 of the

Product Safety Act, 2001, the Minister of Finance and Economic Affairs,

on the advice of the Malta Standards Authority, has made the following

regulations>–

1. The title of these regulations is the Method for Designating Citation and

commencement.

Conformity Assessment Bodies Regulations, 2003.

1.2. These regulations shall become operative on the 1st July,

2003.

1. For the purposes of these regulations, all the definitions of Definitions.

the Act shall apply, and in addition>

2.1.1. “Authority” means the Malta Standards Authority as

established by virtue of the Malta Standards Authority Act, Cap

419<

2.1.2. “the Decision” means Council Decision 93#465#EEC 1

concerning the modules for the various phases of the conformity

assessment procedures and the rules for the affixing and use of the

CE conformity marking, which are intended to be used in the

technical harmonization directives, reproduced as Schedule IV

hereto<

2.1.3. “accreditation” means the procedure by which an

authoritative body gives formal recognition that a body or person

is competent to carry out specific tasks<

Legal Notice 313 of 2001 2 > Malta Standards Authority

(Establishment of the Accreditation Directorate) Order, 2001, lays

OJ No. L 220, 30-08-93, P.23

Published in the Government Gazette No. 17,177 of 20 th December, 2001.

down the establishment, organisation and operation of the

Accreditation Directorate within the Malta Standards Authority,

acting as the only recognised National Accreditation Body in Malta.

2.1.4. “certification” means the process whereby a third

party (Certification Body) provides written assurance that a product,

operation or service conforms with the stipulated requirements<

2.1.5. “conformity” means the fulfilment by a product,

process or service of specified requirements<

2.1.6. “conformity assessment” means any activity

concerned with determining directly or indirectly that relevant

requirements are fulfilled<

2.1.7. “conformity assessment body” is a body that conducts

conformity assessment<

2.1.8. “conformity assessment procedure” means the

procedure by which conformity assessment is attained<

2.1.9. “Directorate” means the Consumer and Industrial

Goods Directorate of the Malta Standards Authority, established

by virtue of L.N. 213 of 2000 - Malta Standards Authority

(Establishment of Directorates) Order, 2000 - published in the

Government Gazette No. 17,002 of 20 th October, 2000.

2.1.10. “inspection” means the examination of a product

design, product, service, process or plant, and the determination

of their conformity with specific requirements or, on the basis of

professional judgement, general requirements<

2.1.11. “inspection body” is a body that performs inspection<

2.1.12. “OJ” means the Official Journal of the European

Union.

2.1.13. “Community” means the European Community.

2.1.14. “CE marking” means the CE conformity marking

consisting of the symbol ‘CE’ as set out in Schedule IV to these

regulations.

1. These regulations set out the conditions for the recognition

of the competence and the subsequent approval of bodies to carry out

work on the certification and#or inspection of industrial products

pursuant to regulations issued under the Act, either to bring Maltese

legislation in line with the European Union’s New Approach Directives,

or as national regulations governing the manufacture and control of

industrial products.

3.2. These regulations shall regulate the method of designating

conformity assessment bodies, the method of determining whether they

fulfil the requirements and the method of withdrawing applicable

decisions.

1 The Authority shall guarantee the confidentiality of data Confidentiality.

obtained on conformity assessment bodies.

4.1.1. The Directorate shall keep a register of conformity

assessment bodies carrying out the tasks of conformity assessment on

the basis of technical regulations.

4.1.2. This register shall be public and published by the

Directorate in the most appropriate form.

1. Maltese bodies wishing to operate within the scope of the CE Marking

Directives and

“New Approach”, CE Marking Directives, as implemented by virtue of implementing

the regulations listed in Schedule I to these regulations, shall follow the regulations

the Act.

procedure listed in regulations 7.1 to 8.6 of these regulations.

5.2. Bodies in Member States of the Community wishing to

operate in Malta within the scope of the “New Approach”, CE Marking

Directives shall>

5.2.1. be notified for this purpose by the Member State in which

they have their registered office<

5.2.2. declare in writing to the Directorate that they intend to

carry out the activity in question and that they agree to the terms of

these regulations<

5.2.3. provide evidence of their notification.

1. Bodies in Malta and in Member States of the Community National

regulations.

wishing to operate within the scope of national regulations that have

been issued for purposes other than bringing Maltese legislation into

line with European Union New Approach Directives, shall follow the

procedure listed in regulations 7.1 to 8.6 of these regulations.

1. The procedure for designating a conformity assessment body

(hereinafter referred to as the “Applicant”) shall commence with the

submission of an application to perform conformity assessment tasks

to the Directorate, in accordance with the general administrative

procedure.

7.2. The application shall contain the following data, and the

following evidence shall be enclosed>

7.2.1. general data (name or firm and address, legal status,

organisational structure with a description of relations between

individual organisational units, and data on the activities that could affect

the impartiality of work)<

7.2.2. document from a court register or from other register<

7.2.3. technical and staff capacities, and the locations of

performance of conformity assessment tasks<

7.2.4. the technical regulation on the basis of which conformity

assessment tasks are to be performed<

7.2.5. the definition of the type, area and scope of tasks and

products to which the tasks refer<

7.2.6. the “Qualifications Dossier” drawn up according to

Schedule II to these regulations and made up of>

7.2.6.1. the “Minimum Criteria Report” prepared by an Expert

chosen by the Authority as per Schedule II (A) to these regulations< and

7.2.6.2. the “Accreditation Certificate” issued by the National

Accreditation Body, or by another National Accreditation Body as

recognised by the Authority, as per Schedule II (B) to these regulations.

7.3 The Directorate shall determine the applicant’s qualifications

on the basis of the documents submitted by the applicant in accordance

with regulation 7.2 of these regulations.

7.3.1. After examining the submitted application, it shall assess

whether it is necessary to make an assessment visit to the applicant’s

head office or any other locations where the activities relevant to the

procedure are performed, or to obtain further evidence.

7.4. When the Applicant demonstrates its qualifications with the

document referred to in regulation 7.2.6, the Directorate shall examine

the compliance of the scope of tasks relevant to the application with the

scope of tasks for which the applicant has been accredited, or with the

scope of tasks referred to in the qualifications report.

7.4.1. The costs of the provision of evidence on qualifications

shall always be covered by the Applicant.

7.4.2. Should the Directorate determine that the submitted

evidence of qualifications is incomplete and fails to demonstrate the

fulfilment of all requirements under the relevant technical regulation, it

may instruct the Applicant to complete them by the end of the procedure.

7.4.3. The Directorate shall regard the Applicant to be qualified

if it has submitted a complete document referred to in regulation 7.2.6

of these regulations as defined by a relevant technical regulation. In

this event, the Directorate shall issue an opinion communicated to the

Minister who shall issue a decision on designation to perform particular

tasks in conformity assessment procedures.

7.4.4. Should the scopes of tasks referred to in regulation 7.4 of

these regulations fail to agree, the Directorate shall define the Applicant’s

scope of tasks which are not covered in the submitted documents, and

shall instruct the Applicant to submit additional evidence, or shall adopt

an opinion as to what type of additional evidence is needed. This opinion

is communicated to the Minister who shall issue the relevant decision.

7.5. If the Applicant fails to submit the document referred to in

regulation 7.2.6 of these regulations and is instructed by the Directorate

to subsequently submit evidence on meeting the conditions for carrying

out the tasks, the Directorate shall issue an opinion which is

communicated to the Minister who shall adopt a decision on obtaining

additional evidence.

7.6. On the basis of facts found out, the Directorate shall issue

an opinion on>

(a) the Applicant’s fulfilment of the conditions for the

issuing and extension of the decision, and the opinion on the total

or partial compliance of the document with the requirements of

the relevant technical regulation in relation to regulation 7.2.6 of

these regulations<

(b) the measures necessary for the elimination of

deficiencies found out during the surveillance pursuant to the

provisions of regulations 7.1 to 7.5 of these regulations<

(c) notification under regulation 8.1 of these regulations.

that shall be communicated to the Minister who shall issue a decision

on the application.

7.7 The decision on designating a conformity assessment body

shall contain at least the following data>

7.7.1. the title of the relevant technical regulation<

7.7.2. a detailed description of the scope of work determined in

the decision for which qualifications have been found out<

7.7.3. period of validity of the decision<

7.7.4. identification number assigned to the conformity

assessment body by the Minister<

7.7.5. name of signatory who has been empowered to sign on

documents issued by the conformity assessment body.

7.8. A decision shall be issued to the conformity assessment body

which has demonstrated its credentials by means of the “Qualifications

Dossier” made up of a “Minimum Criteria Report” not older that three

months, for a maximum of four years, and an “Accreditation Cerificate”

for not longer than the duration of validity of the accreditation certificate.

7.9. The decision on designating the conformity assessment body

may be extended after the expiry of the period of validity, or after the

expiry of the validity of the documents referred to in regulation 7.8

above, if the applicant submits the valid evidence referred to in regulation

7.2 of these regulations.

7.10. The conformity assessment body may subcontract some

clearly defined tasks to a subcontractor, if the sub-contractor can provide

evidence that it meets the prescribed requirements referred to in

regulation 7.2 of these regulations.

7.10.1. The subcontracted tasks shall supplement the activities

carried out by the conformity assessment body, and shall form, with

them, an indivisible whole.

7.10.2. The conformity assessment body shall be able to provide

proof of the qualification of the sub-contractor, keep records thereof

and assume total responsibility for the work executed by the sub-

contractor.

7.10.3. The conformity assessment body shall keep a register of

sub-contractors and the tasks granted to them.

1. The conformity assessment body shall permanently meet Monitoring,

the requirements for designation, keep records of all procedures of Surveillance

Withdrawals.

conformity assessment for which it has been designated, and

immediately notify the Directorate of any changes that could affect its

qualification, the scope of activities from the decision or the fulfilment

of the requirements for designation.

8.1.1. The conformity assessment body shall keep the records of

all working tasks carried out and their results for at least ten years.

8.2. At the request of the Directorate, the conformity assessment

body shall take part in qualification tests or other comparisons

determined for conformity assessment bodies.

8.2.1. The conformity assessment body shall allow the

Directorate access to all data related to the fulfilment of requirements

for conformity assessment, and access to all premises where the tasks

included in the scope of conformity assessment, as defined in the issued

decision, are carried out.

8.3. Bodies carrying out industrial product certification or

inspection work in accordance with the above provisions shall have

their activities monitored in accordance with the provisions of Schedule

III to these regulations.

8.4. The Directorate may carry out extraordinary surveillance of

the conformity assessment body if the regularity of its actions is in

doubt.

8.4.1. If necessary, it may involve the National Accreditation

Body in the implementation of extraordinary surveillance.

8.5. Should the surveillance referred to in regulations 8.3 and

8.4 of these regulations found out that the conformity assessment body

does not comply with the requirements for designation, the Directorate

shall issue a decision determining measures and a deadline for the

elimination of irregularities.

8.5.1. The conformity assessment body shall be obliged to notify

the Directorate of the implementation of the measures determined in

the decision by the set deadline.

8.5.2. Should the conformity assessment body fail to eliminate

the determined irregularities by the set deadline, the Minister shall issue

a decision on withdrawal and remove the name of that conformity

assessment body from the register referred to in regulations 4.1.1 and

4.1.2 of these regulations.

8.6. The Minister shall also withdraw a decision in the event

that the conformity assessment body notifies the Directorate that it

wishes to cease performing the tasks referred to in that decision.

8.7. Manufacturers or producers of products falling within the

scope of the provisions of regulation 3.1 of these regulations shall, in

order to certify or inspect their products, in accordance with the

provisions of the relevant regulations, make use of the bodies that appear

on the list pubished in the register referred to in regulations 4.1.1 and

4.1.2 of these regulations.

1. The body in question shall, inter alia, co-operate with the

competent authorities responsible for implementation of the regulations

and contribute to the work of the relevant group of bodies meeting at

national and#or European level.

9.2. For market surveillance work, which also includes the

inspections carried out by the bodies, the latter shall>

9.2.1. send to the Directorate the Type Examination Certificates

they issue or other testimonials issued further to the application of the

regulations in question, as and when these are officially requested<

9.2.2. where possible, facilitate the work of the competent

authorities during the conduct of sample checks.

1. In the event of its being established that a body, producer

or manufacturer is engaged in activities that breach the terms of these

regulations, Part IV of the Act is applicable and the granted authorisation

shall be suspended or revoked or, if the body is a notified body from

abroad, the authority responsible for notification will be informed.

10.1.1. In such cases, the name of the body shall be struck from

the register provided for under regulations 4.1.1 and 4.1.2 of these

regulations.

1. The Minister shall inform the Commission and the other

Member States of the designation and withdrawal of designation of

conformity assessment bodies carrying out procedures under technical

regulations which are subject to regulation 5.1 of these regulations.

B

Schedule I

IMPLEMENTATION OF THE "NEW APPROACH",

CE MARKING DIRECTIVES IN MALTA

The implementation dates of the regulations published by the Ministry of Finance and

Economic Affairs, acting on the advice of the Malta Standards Authority, are given in the

table below. All current publications in the Government Gazette are available on the

Malta Standards Autority website (www.msa.org.mt) as downloadable documents.

Published originally under the Quality Control (Exports, Imports and Local Goods)

Act and kept in force by virtue of Article 41 6f the new Product Safety Act, Cap.

427

L.N. 16 of 1996

L.N. 52 of 1996

L.N. 122 of 1998

L.N. 229 of 1998 1 Simple pressure vessels

1 23rd October 1998

1' March 1998

I

1 '' March 1999

L.N. 23 of 1999

1' April 1999

L.N. 24 of 1999

L.N. 107 of 1999

1" January 2000

potentially explosive atmospheres

(94/9/EC)

Published under the new Metrology Act, Act No: XXV of 2002

--

-

,

[ 3 1 December

~

of 2002

Non-Autom

1" January 2004

'

j 2002

Instruments (90/384/EC)

B

Published following the enactment of the new Product Safety Act, Cap. 427, in

March 2001

Coming into force

Legal Notice

Citation

Published

-

L.N. 66 of 2001

30fh March 2001

1 " April 200 1

(90/3 8 5/EEC)

L.N. 23 1 of 2001

1 " July 2002

Recreational craft (94/25/EC)

2Sfh September 2002

L.N. 249 of 200 I

Lifts (95/16/EC)

26Ih October 2001

1 " July 2002

I

L.N. 250 of 2001

1 " July 2002

26Ih October 2001

I

Is' July 2002

2"d November 2001

-

L.N. 329 of 2001

1 " January 2002

2Sfh December 2001

telecommunications terminal equipment

and mutual recognition of their

conformity (1 999/05/EC)

1 '' January 2003

L.N. 61 of 2002

In-vitro diagnostic medical devices

12" March 2002

I

1 12Ih March 2002

I 1 January 2003

I New hot-water boilers fired with liquid

L.N. 62 of 2002

"

I

or gaseous fuels (efficiency requirements)

I

(92/42/EEC)

i

__~______

I I 2Ih March 2002

L.N. 63 of 2002

Energy efficiency requirements for

1 " January 2003

'

household electric refngerators, freezers

and combinations thereof (96/57/EC)

I

-

_

.

.

L.N. 64 of 2002

Noise emission in the environment by

I 2Ih March 2002

equipment for use outdoors

i

(2000/14/EC)

i

1 3d September 2002

L.N. 248 of 2002

Pressure equipment (97/23/EC)

L.N. 33 I of 2002

Transportable pressure equipment

I (1 999/36/EC)

I Interoperability of the trans-European

L.N. 332 of 2002

'

I high-speed rail system (96/48/EC)

L.N. 333 of 2002

Cableway installations designed to carry

persons (2000/9/EC)

1 12Ih November 2002

I L.N. 334 of 2002

Interoperability of the trans-European

20fh April 2003

; r - - ----____.-.

conventional rail system (2001/16/EC)

~

[??%nxG2%3--.-'

~

i L.N. 47 of 2003

1 Medical devices (93/42/EEC)

3 1 January 2003

i

B

Schedule I1

RECOGNITION OF TECHNICAL COMPETENCE

This Schedule sets out the framework and conditions for recognition of the technical

competence of bodies, required under regulation 7.2.6 of these regulations, in carrying out

industrial product certification and/or inspection work within the framework of the

application of the regulatory provisions falling under the Act.

In all cases, responsibility for their approval lies with the Minister of Finance and

Economic Affairs, acting on the advice of the Directorate.

Recognition of technical competence involves the preparation by the body concerned of a

“Qualifications Dossier” for this purpose, composed of two documents, namely a

“Minimum Criteria Report” issued by an Expert chosen by the Directorate and an

“Accreditation Certificate” issued by the National Accreditation Body, or by another

National Accreditation Body as recognised by the Authority

A. CRITERIA TO BE TAKEN INTO ACCOUNT FOR

THE EXPERT’S REPORT

1. The body, its director and the staff responsible for carrying out the verification

tests shall not be the designer, manufacturer, supplier or installer of the product

which they inspect, nor the authorised representative of any of these parties. They

shall not become either involved directly or as authorised representatives in the

design, construction, marketing or maintenance of the product. This does not

preclude the possibility of exchanges of technical information between the

manufacturer and the body.

2. The body and its staff shall carry out the verification tests with the highest degree

of professional integrity and technical competence and shall be free from all

pressures and inducements, particularly financial, which might influence their

judgement or the results of the inspection, especially from persons or groups of

persons with an interest in the result of verifications.

3. In addition to being technically competent, applicant bodies shall be legal persons

under public law, legal persons under private law, private-sector bodies or

associations of these, with a legal form of public or private limited companies,

whose financial standing can be proved by means of the following supporting

documents or records

Certificate of insurance and tax observance;

Balance sheets for the last three years;

Certificate stating that the body is not bankrupt, in liquidation, being

wound up, in official receivership, in bankruptcy proceedings or in a

similar situation arising from legal provisions;

Certificate stating that the body is not in proceedings for bankruptcy,

official receivership, creditor arrangements or other similar proceeding

under legal provisions.

4. The body shall have at its disposal the necessary staff and possess the necessary

facilities to enable it to perform properly the administrative and technical tasks

connected with verification; it shall also have access to the equipment required for

special verification.

5. The staff responsible for testinghnspection shall have

sound technical and professional training,

knowledge of the Directive or regulations being applied,

satisfactory knowledge of the requirements of the tests they carry out and

adequate experience of such tests,

knowledge of the technology used to manufacture the products to

be checked, of the way they are used, of problems that may arise during

their use and the likely consequences of these,

the ability to exercise professional judgment in respect of the conformity

of the product with the requirements of the regulations being applied,

the ability to draw up the certificates, records and reports required to

authenticate the performance of the tests.

6 . In each instance, the body shall be in a position to assess the conformity of

products against the essential requirements set out in the regulations and

u Where harmonised standards are used for conformity assessment,

compliance with the essential requirements is assumed.

Where harmonised standards are not used for conformity assessment, or

where standards do not specify a conformity assessment method, the body

shall use its own method and be able to demonstrate that this method

meets all the essential requirements for assessing the conformity of the

product .

7. The impartiality of inspection staff shall be guaranteed. Their remuneration shall

not depend on the number of tests carried out or on the results of such tests.

8. The body shall take out civil liability insurance for the services it provides and

shall be able to justify the amount of this. This does not apply if its liability is

B

assumed by the Government of Malta in accordance with national law, or the

Government of Malta itself is directly responsible for the tests.

9. The staff of the body shall be bound to observe professional secrecy with regard to

all information gained in carrying out its tasks (except vis-a-vis the competent

administrative authorities) under a specific Directive or any provision of national

regulations giving effect to it.

B. CRITERIA TO BE TAKEN INTO ACCOUNT

FOR ACCREDITATION

1. Accreditation shall be based on the accreditation criteria defjned in international

standards, as applied by the National Accreditation Body, or by another National

Accreditation Body as recognised by the Authority.

2. The applicant body shall specify

o The products or group of products whose conformity is to be assessed;

The standards used to evaluate product conformity, or the body's own

method where standards are not used;

The conformity assessment procedures (modules) provided for in the

Directive or law in question and selected for use.

International standards as applied by the National Accreditation Body, or by

another National Accreditation Body as recognised by the Authority, depend on

the module applied by the body, as provided for in Council Decision 93/465/EEC,

reproduced as Schedule IV to these regulations, or on the corresponding procedure

provided for in the regulations in question.

3. During evaluation of the body to be accredited, account shall be taken of the

following

The guidelines for the application of the international standards issued by

o

the EA (European Co-operation for Accreditation);

The Special Guidelines issued by the EA concerning additional

o

requirements for Notified Bodies;

The documents from the European Commission's CERTIF series

o

containing additional guidelines for the implementation of the Directives

and on Notified Bodies.

4. After approval has been granted, bodies shall be subject to monitoring in order to

ensure their consistent compliance with the above requirements, in accordance

with the regulations for Accredited Bodies as established by the National

Accreditation Body, or by another National Accreditation Body as recognised by

the Authority.

5. In Malta, accreditation certificates are issued by the National Accreditation Body,

which was set up pursuant to Legal Notice 313 of 2001: Malta Standards

Authority (Establishment of the Accreditation Directorate) Order, 2001 , acting on

the advise of the Accreditation Advisory Board. .

B

Schedule I11

MONITORING OF BODIES

As part of the surveillance referred to in regulations 7.1 to 7.6 of these regulations, bodies

shall be monitored by the Directorate, as follows

1. Each year, at the end of each four-month period, the body sends to the

Directorate a list of all the inspections or certifications it has carried out

during the period in question.

2. The body sends to the Directorate the quality and procedural handbook and

details of the inspections or certifications it carries out.

3. Monitoring includes

A check of the documentation submitted pursuant to paragraph 2

above;

A sample check of manufacturers on whom inspections or

certifications have been completed;

Completion of at least one site inspection or certification;

Evaluation of compliance with the obligations set out in paragraphs 1

and 2 of Schedule I11 to these regulations.

4. At any stage, the Directorate may involve the National Accreditation Body in

drawing up the monitoring programme and during its execution.

Schedule IV

Council Decision 93/465/EEC

No L 220123

Official Journal of the European Communities

-c_-

COUNCIL DECISION

of 22 July 1993

concerning the modules for the various phases of the conformity assessment procedures and the

rules for the affixing and use of the CE conformity marking, which are intended to be used in

the technical harmonization directives

(93/465/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Whereas such confordty should be assured without

imposing unnecessarily onerous conditions on

manufacturers, and by means of clear and

Having regard to the Treaty establishing the European

comprehensible procedures;

Economic Community, and in particular Article lOOa

Whereas limited flexibility should be introduced as

regards use of additional modules, or variations in'the

Having regard to the proposal from the Commission (I),

modules, when the specific circumstances of a particular

sector or directive so warrant, but not to such a degree as

In cooperation with the European Parliament (z),

to undercut the purpose of the current Decision and only

when explicitly justified;

Having regard to the opinion of the Economic and Social

Committee ('),

Whereas in the abovementioned Resolution of

2 1 December 1989 the Council approved as a guiding

principle the adoption of common rules on the use of the

Whereas Council Decision 90/683/EEC of 1 3 December

CE marking;

1990 concerning the modules for the various phases of

the conformity assessment procedures which are intended

to be used in the technical harmonization directives (')

Whereas in its Decision 90/683/EEC the Council laid

needs to be substantially amended in various places;

down that the industrial products covered by the

whereas it is necessary, in a spirit of clarity and

technical harmonization directives can be placed on the

rationality, to consolidate its provisions by means of this

market only after the manufacturer has affixed the CE

marking to them;

Whereas the Council adopted a Resolution on

Whereas a single CE marking should be used in order to

21 December 1989 concerning a global approach to

facilitate controls on the Community market by

conformity assessments (I);

inspectors and to clarify the obligations of economic

operators in respect of marking under the various

Community regulations;

Whereas the introduction of harmonized methods for the

assessment of conformity and the adoption of a common

doctrine for their implementation are likely to facilitate

Whereas the aim of the CE marking is to symbolize the

conformity of a product with the levels of protection of

the adoption of future technical harmonization directives

concerning the placing on the market of industrial

collective interests imposed by the total harmonization

products and thus be conducive to the implementation of

directives and to indicate that the economic operator has

the internal market;

undergone all the evaluation procedures laid down by

Community law in respect of his product,

Whereas such methods should ensure that products are in

full conformity with the essential requirements laid down

in the technical harmonization directives, in order to

provide, in particular, for the health and safety of users

HAS DECIDED AS FOLLOWS

and consumers;

OJ No C 160, 20. 6. 1991, p. 14; and

Article 1

OJ No C 28, 2. I. 1993, p. 16.

(') OJ No C 125, 18. 5. 1992. p. 178;

OJ No C 115, 26. 4. 1993, p. 117; and

The procedures for conformity assessment which

I.

Decision of 14 July 1993 (not yet published in the Official

are' to be used in the technical harmonization directives

relating to the marketing of industrial products will be

( I ) OJ No C 14, 20. 1 . 1992, p. 15; and

chosen from among the modules listed in the Annex and

OJ No C 129, 10. 5. 1993, p. 3.

in accordance with tine criteria set out in this Decision

(') OJ No L 380, 31. 12. 1990, p. 13.

(') OJ NO C 10, 16. 1. 1990, p. I .

and in the general guidelines in the Annex.

B

8. 93

Official Journal of the European Communities

No 1-220124

equipment designed for use within certain voltage

These procedures may only depart from the modules

when the specific circumstances of a particular sector or

limits ( I ) within the scope of CE marking procedures,

directive so warrant. Such departures from the modules

and, in particular, whether safety is being compromised.

It shall also review any problems raised by the issue of

must be limited in extent and must be explicitly justified

in the relevant directive.

overlapping Council directives, and whether any further

Community measures are required.

2. This Decision lays down rules for affixing the CE

conformity marking provided for in Community

Article 2

legislation concerning the design, manufacture, placing on

the market, entry into service or use of industrial

1. Decision 90/683/EEC is hereby repealed.

products.

References to the Decision repealed shall be

2. construed as references to this Decision.

3. The Commission shall report periodically on the

functioning of this Decision, and on whether conformity

assessment and CE marking procedures are working

satisfactorily or need to be modified.

Done at Brussels, 22 July 1993.

No later than the end of the transitional period in 1997,

or earlier if the matter is found to be urgent, the

For the Council

Commission shall also report back on any special

The President

problems raised by the incorporation of Council Directive

73/23/EEC of 19 February 1973 relating to electrical

M. OFFECIERS-VAN DE WIELE

No L 220125

Official Journal of the European Communities

ANNEX

CONFORMITY ASSESSMENT PROCEDURES AND CE MARKING IN THE TECHNICAL

HARMONIZATION DIRECTIVES

I. GENERAL GUIDELINES

A. The principal guidelines for the use of conformity assessment procedures in technical harmonization

ditectives are the following

(a) the essential objective of a conformity assessment procedure is to enable the public authorities

to ensure that products placed on the market conform to the requirements as expressed in the

provisions of the directives, in particular with regard to the health and safety of users and

consumers;

(b) conformity assessment can be subdivided into modules which relate to the design phase of

products and to their production phase;

(c) as a general rule a product should be subject to both phases before being able to be placed on

the market if the results are positive (*);

(d) there are a variety of modules which cover the two phases in a variety of ways. The directives

must set the range of possible choices which can be considered by the Council to give the public

authorities the high level of safety they seek, for a given product or product sector;

(e) in setting the range of possible choices open to the manufacturer, the directives, will take into

consideration, in particular, such issues as the appropriateness of the modules to the type of

products, the nature of the risks involved, the economic infrastructures of the g;ven sector (e.g.

existence or non-existence of third parties), the types and importance of production, etc. The

factors that have been taken into account must be explicitly spelled out by the Commission in

these directives;

(f) the directives will, in setting the range of possible modules for a given product or product

sector, attempt to leave as wide a choice to the manufacturer as is consistent with ensuring

compliance with the requirements.

The directives will set out the criteria governing the conditions in which the manufacturer

chooses the most appropriate modules for his production from the modules laid down by the

directives;

(g) the directives should avoid imposing unnecessarily modules which would be too onerous

relative to the objectives of the directive concerned;

(h) notified bodies should be encouraged to apply the modules without unnecessary burden for the

economic operators. The Commission, in cooperation with the Member States, must ensure thar

close cooperation is organized between the notified bodies in order to ensure consistent

technical application of the modules;

(i) in order to protect the manufacturers, the technical documentation provided to notified bodies

has to be limited to that which is required solely for the purpose of assessment of conformity.

Legal protection of confidential information is required;

(j) whenever directives provide the manufacturer with the possibility of using modules based on

quality assurance techniques, the manufacturer must also be able to have recourse to a

combination of modules not using quality assurance, and vice versa, except where compliance

with the requirements laid down by the directives requires the exclusive application of a certain

procedurc;

(k) for the purposes of operating the modules, Member States must notify on their own

responsibility bodies under their jurisdiction which they have chosen from the technically

competent bodies complying with the requirements of the directives. This responsibility involves

the obligation for the Member States to ensure that the notified bodies permanently have the

technical qualifications required by the directives and that the latter keep their competent

national authorities informed of the performance of their tasks. Where a Member State

withdraws its notification of a body, it must take appropriate steps to ensure that the dossiers

are processed by another notified body to ensure continuity;

( * ) The specific directives m a y provide for different arrangements

Official Journal of the European Communities

,

(I) in addition, with regard to conformity assessment, the sub-contracting of work shall be subject

to certain conditions guaranteeing

- the competence of the establishment operating as sub-contractor, on the basis of conformity

with series EN 45 000 standards, and the capability of the Member State that has notified

the sub-contracting body to ensure effective monitoring of such compliance,

- the ability of the body notified to exercise effective responsibility for the work carried out

under subcontract;

(m) notified bodies which can prove their conformity with harmonized standards (EN 45 000

series), by submitting an accreditation certificate or other documentary evidence, are presumed

to conform to the requirements of'the directives. Member States having notified bodies unable

to prove their conformity with the harmonized standards (EN 45 000 series) may be requested

to provide the Commission with the appropriate supporting documents on the basis of which

notification was carried out;

(n) a list of notified bodies must be published by the Commission in the Official ]ournaI o f the

European Communities and constantly updated.

B. The principal guidelines for the affixing and use of the CE marking are the following

(a) The .CE marking symbolizes conformity to all the obligations incumbent on manufacturers for

the product by virtue of the Community directives providing for its affixing.

Thus, such conformity is not limited to the essential requirements relating to safety, public

health, consumer protection, etc., as certain directives may impose specific obligations not

necessarily forming part of the essential requirements.

(b) The CE marking affixed to industrial products symbolizes the fact that the natural or legal

person having affixed or been responsible for the affixing of the said marking has verified that

the product conforms to all the Community total harmonization provisions which apply to it

and has been the subject oi the appropriate conformity evaluation procedures.

(c) Where the industrial products are subject to other directives concerning other aspects and which

also provide for the affixing of the CE marking, the latter must indicate that the products are

also presumed to conform to the provisions of those other directives.

However, where one or more of these directives allow the manufacturer, during a transitional

period, to choose which arrangements to apply, the CE marking indicates conformity to the

provisions only of those directives applied by the manufacturer. In this case, particulars of the

directives applied, as published in the Officiul Journal of the Europeun Communities, must be

given in the documents, noticcs or instructions accompanying the products or, where

appropriate, on the data plate.

(d) 1. The CE conformity marking must consist of the initials 'CE' taking the following form

I f the CE marking is reduced OF enlarged the proportions given in the above graduated

drawing must be respected.

2. Where the dircctivc concerned does not impose specific dimensions, the CE marking must

have a hcight of at least 5 mrn.

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Official Journal of the European Communities

3. The CE marking must be affixed to the product or to its data plate. However, where this is

not possible or not warranted on account of the nature of the product, it must be affixed to

the packaging, if any, and to the accompanying documents, where the directive concerned

provides for such documents.

4. The CE marking must be affixed visibly, legibly and indelibly.

( e ) Any industrial product covered by the technical harmonization directives based on the principles

of the global approach must bear the CE marking, save where the specific directives provide

otherwise; such exceptions constitute derogations not from the marking requirement but from

the administrative procedures for conformity evaluation, which may in certain cases be

considered too cumbersome. Appropriate grounds must accordingly be given for any exception

to or derogation from the marking requirement.

The CF. marking is the only marking which certifies that the industrial products conform to the

directives based on the principles of the global approach.

Member States must refrain from introducing into their national regulations any reference to a

conformity marking other than the CE marking in connection with conformity to all the

provisions contained in the directives o n CE marking.

(f) The CE marking must be affixed a t the end of the production control phase.

(9) The CE conformity marking must be followed by.the identification number of the notified body

within the meaning of paragraph 1.A where the said body is involved in the production control

phase within the meaning of this Decision.

Such identification numbers must be assigned by the Commission as part of the body

notification procedure. The Commission must publish lists of the notified bodies in the Official

Journal of the European Communities; such lists must be updated regularly.

A notified body must be assigned the same number when it is notified under several directives.

The Commission must ensure that each notified body receives a single identification number,

however many directives it is notified under.

(h) It is necessary to lay down provisions concerning the use of certain products. In this case, the

CE marking and the identification number of the notified body may be followed by a pictogram

or any other mark indicating, for example, the category of use.

(i) The affixing for any other marking liable to deceive third parties as to the meaning and form of

the CE marking must be prohibited.

(j) A product may bear different marks, for example marks indicating conformity to national or

European standards or with traditional optional directives, provided such marks are not liable

to cause confusion with the CE marking.

Such marks may therefore only be affixed to the product; its packaging or the documentation

accompanying the product on condition that the legibility and visibility of the CE marking are

not thereby reduced.

(k) The CE marking must be affixed by the manufacturer or his agent established within the

Community. In exceptional, duly warranted cases, the specific directives may provide that the

CE marking can be affixed by the person respcnsible for placing the product on the Community

market.

The identification number of the notified body must be affixed under its responsibility either by

the body itself or by the manufacturer or his agent established within the Community.

(I) Member States must take all provisions of national law necessary to exclude any possibility of

confusion and to prevent abuse of the CE marking.

Without prejudice to the provisions in the directive concerned relating to the application of the

safeguard clause, where a Member State establishes that the CE marking 'has been affixed

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Official Journal of the European Communities

unduly, the manufacturer, his agent or, exceptionally, where the specific directives so provide,

the person responsible for placing the product in question on the Community market is obliged

to make the product comply and to end the infringement under conditions imposed by the

Member State. Where non-compliance continues, the Member State must take all appropriate

measures to restrict or prohibit the placing on the market of the product in question or to

ensure that it is withdrawn from the market in accordance with the procedures laid down in the

safeguard clauses.

11. MODULES FOR CONFORMITY ASSESSMENT

Explanatory notes

Specific directives may allow the CE marking to be affixed to the packaging or the accompanying

documentation, instead of to the product itself.

The declaration of conformity or the certificate of conformity (whichever of the two applies in the

directive concerned) must cover either individual or several products and shall either accompany the

product(s) covered or be kept by the manufacturer. The appropriate solution for the directive concerned

will be specified.

References to Articles refer to the standard paragraphs of Annex 1I.B to the Council resolution of 7 May

1985 (OJ No C 136, 4. 6. 1985, p. I ) , which have become standard Articles in the 'new approach'

,

ditecti ves.

The development of computerized communication of certificates and other documents issued by notified

bodies is envisaged within INSIS.

Specific directives may use modules A, C and H with additional provisions containing supplementary

requirements which figure in the boxes in the modules.

Module C is designed t o be used in combination with module B (EC type-examination). Modules D, E

and F will also normally bc used in combination with module B; however, in special cases (for example,

when dealing with certain products of very simple design and construction) they may be used on their

own.

Module A (internal production control)

1. This module describes the procedure whereby the manufacturer or his authorized representative

established within the Community, who carries out the obligations laid down in point 2, ensures and

declares that the products concerned satisfy the requirements of the directive that apply to them. The

manufacturer or his authorized manufacturer established within the Community must affix the CE

marking to each product and draw up a written declaration of conformity.

2. The manufacturer must establish the technical documentation described in paragraph 3 and he or his

authorized representative established with the Community must keep it for a period ending at least

I 0 years ( * ) after the last product has been manufactured at the disposal of the relevant national

authorities for inspection purposes.

Where neither the manufacturer nor his authorized representative is established within the

Community, the obligation to keep the technical documentation available is the responsibility of the

person who places the product o n the Community market.

3. Technical docurnentation must enable the conformity of the product with the requirements of the

directive to be assessed. It must, as far as relevant for such assessment, cover the design, manufacture

and operation of the product (").

( * ) The specific directives may alter this period.

The content of the technical documentation shall be laid down directive by directive i n accordance with the products

(")

concerned.

For example, the documentation must contain so far as relevant for assessment

- a general description of the product,

- conceptual design and manufacturing drawings and schemes o f components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of said drawings and schemes and the operation o f

the product,

- a list of the standard5 referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted

to mcet the essemial requirements of the directive where the standards referred to in Article 5 have not been

applied,

- results ot' design calculations madr, examinations carried out> etc.,

- rest rcportr.

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Official Journal of the European Communities

4. The manufacturer or his authorized representative must keep a copy of the declaration of conformity

with the technical documentation.

5. The manufacturer must take all measures necessary in order that the manufacturing process ensures

compliance of the manufactured products with the technical documentation referred to in point 2

and with the requirements of the directive that apply to them.

Module Aa

This module consists of module A, plus the following supplementary requirements

For each product manufactured one o r more tests o n one or more specific aspects of the product

must be carried out by the manufacturer or on his behalf (*). The tests are carried out on the

responsibility of a notified body chosen by the manufacturer.

On the responsibility of the notified body, the manufacturer must affix the former’s identification

number during the manufacturing process.

1‘) If this option is adopted in a specific directive, the products concerned and the tests to be carried out must be

specified.

or

A notified body chosen by the manufacturer must carry out o r have carried o u t product checks at

random intervals. An adequate sample of the final products, taken on site by the notified body,

must be examined and appropriate tests as set out in the relevant standard(s) referred to in Article

5, or equivalent tests, must be carried out to check the conformity of the product with the relevant

requirements of the directive.

In those cases where one o r more of the products checked do not conform the notified body must

take appropriate measures.

The product checking must include the following aspects

(Relevant aspects must be specified here such as for example the statistical method to be applied,

the sampling plan with its operational characteristics, etc.)

On the responsibility of the notified body, the manufacturer must affix the former’s identification

number during the manufacturing process.

Module B (EC type-examination)

1. This module describes that part of the procedure by which a notified body ascertains and attests that

a specimen, representative of the production envisaged, meets the provisions of the ‘directive that

apply to it.

2. The application for the EC type-examination must be lodged by the manufacturer or his authorized

representative established within the Community with a notified body of his choice.

The application must include

- the name and address of the manufacturer and, if the application is lodged by the authorized

representative, his name and address in addition,

- a written declaration that the same application has not been lodged with any other notified

body,

- the technjcal documentation, as described in point 3.

The applicant must place at the disposal of the notified body a specimen, repesentative of the

production envisaged and hereinafter called ‘type’ (*). The notified body may request further

specimens if needed for carrying out the test programme.

( * J A type may cover several versions of the product provided that the differences between the versions do not affect the

level of safety and the other requirements concerning the performance of the product.

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Official Journal of the European Communities

3. The technical documentation must enable the confarmiry of :he product with the requirements of the

directive to be assessed. It must, as far as relevant for such assessment, cover the design, manufacture

and operation of the product (*).

4. The notified body must

4.1. examine the technical documentation, verify that the type has been manufactured in conformity

with the technical documentation and identify the elements which have been designed in

accordance with the relevant provisions of the standards referred to in Article 5, as well as the

components which have been designed without applying the relevant provisions of those

standards;

4.2. perform or have performed the appropriate examinations and necessary tests to check whether,

where the standards referred to in Article 5 have not been applied, the solutions adopted by the

manufacturer meet the essential requirements of the directive;

4.3. perform or have performed the appropriate examinations and necessary tests to check whether,

where the manufacturer has chosen to apply the relevant standards, these have actually been

applied;

4.4. agree with the applicant the location where the examinations and necessary tests will be carried

out.

5. Where the type meets the provisions of the directive, the notified body must issue an EC

type-examination certificate to the applicant. The certificate must contain the name and address of

the manufacturer, conclusions of the examination, conditions for its validity and the necessary data

for identification of the approved type (").

A list of the relevant of the technical documentation must be annexed to the certificate and a copy

kept by the notified body.

If the manufacturer is denied a type certification, the notified body must provide detailed reasons for

such denial.

Provision must be made for an appeals procedure.

6. The applicant must inform the notified body thaF holds the technical documentation concerning the

EC type-examination certificate of all modifications to the approved product which must receive

additional approval where such changes may affect the conformity with the essential requirements or

the prescribed conditions for use of the product. This additional approval is given in the form of an

addition to the original EC type-examination certificate.

7. Each notified body must communicate to the other notified bodies the. relevant information

concerning the EC type-examination certificates and additions issued and withdrawn ( * ).

8. The other notified bodies may receive copies of the EC type-examination certificates and/or their

additions. The Annexes to the certificates must be kept at the disposal of the other notified

bodies.

9. The manufacturer or his authorized representative must keep with the technical documentation

copies of EC type-examination certificates and their additions for a period ending at least 10

years ( * * * ' ) after the last product has been manufactured.

Where neither the manufacturer nor his authorized representativc is established within the

Community, the obligation to keep the technical documentation available is the responsibility of the

person who places the product on the Community market.

( * ) The content of the technical documenration musr be laid down directive by directive i n accordance with the

products concerned.

For example, the documentation musr contain as far a s i s relevant for .assessnienr

- a general rype-description,

- conceptual design and manufacturing drawings and schemes of components. sub-assernhlies, circuits, erc.,

- descriptions and explanations necessary for the understanding of said drawings and schemes and the uperation

of the product,

.- a list of the standards referred to in Article 5 , applied in full or i n part. and descriptions nf the solurions

adopted to meet rhe essential requirements of rhe directive where the standards refrrred ro in Article 5 have nor

been applied,

- result\ of desigii calculation< made, exaniinarions carried out, etc.,

- rest reporrs.

The specific directives may provide for the certificate to have a period o f validiry.

( * ' * ) The specific directives may providc for diffrrenr arrangements.

The specific directives may altcr this period.

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Official Journal of the European Communities

Module C (conformity to type)

1. This niodule describes that part of the procedure whereby the manufacturer o r his authorized

representative established within the Community ensures and declares that the products concerned

are in conformity with the type as described in the EC type-examination certificate and satisfy the

requirements of the directive that applies to them. The manufacturer or his authorized representative

established within the Community must affix the CE marking to each product and draw up a

written declaration of conformity.

2. The manufacturer must take all measures necessary t o ensure that the manufacturing process assures

compliance of the manufactured products with the type as described in the EC type-examination

certificate and with the requirements of the directive that apply t o them.

3. The manufacturer o r his authorized representative must keep a copy of the declaration of conformity

for a period ending at least 10 years (*) after the last product has been manufactured.

Where neither the manufacturer nor his authorized representative is established within the

Community, the obligation t o keep the technical documentation available is the responsibility of the

person who places the product on the Community market.

Possible supplementary requirements

For each product manufactured one or more tests on one or more specific aspects of the product

must be carried out by the manufacturer or on his behalf (*). The tests must be carried out on the

responsibility of a notified body, chosen by the manufacturer.

On the responsibility of the notified body, the manufacturer must affix the former's identification

number during the manufacturing process.

If this option is adopted in a specific directive, the products concerned and the rests to be carried out must he

(')

specified.

or

A notified body chosen by the manufacturer must carry out o r have carried out product checks at

random intervals. An adequate sample of the final products, taken o n site by the notified body,

must be examined and appropriate tests as set out in the relevant standard(s) referred to in

Article 5, or equivalent tests, must be carried out to check the conformity of production with the

relevant requirements of the directive. In those cases where one or more of the products checked do

not conform, the notified body must take appropriate measures.

The product checking must include the following aspects

(Relevant aspects must be specified here such as for example the statistical method to be applied,

the sampling plan with its operational characteristics, etc.)

On the responsibility of the notified body, the manufacturer must affix the former's identification

number during the manufacturing process.

Module D ("),

(production quality assurance)

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of

point2 ensures and declares that the products concerned [are in conformity with the type as

described in the EC type-examination certificate and] satisfy the requirements of the directive that

apply to them. The manufacturer o r his authorized representative established within the Community

must affix the CE marking to each product and draw up a written declaration of conformity. The

CE marking must be accompanied by the identification symbol of the notified body responsible for

EC monitoring as specified in point 4.

2. The manufacturer must operate an approved quality system for production, final product inspection

and testing as specified in paragraph 3 and is subject t o monitoring as specified in point 4.

("1 The specific directives may alter this period.

Where this module is used without module B

- points 2 and 3 of module A must be added between points 1 and 2 in order to incorporate the need for technical

documentation,

- the words in square brackets must be deleted.

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Official Journal of the European Communities

3. Quality system

The manufacturer must lodge an application for assessment of his quality system with a

I

notified body of his choice, for the products concerned.

The application must include

- all relevant information for the product category envisaged,

- the documentation concerning the quality system,

- if applicable, the technical documentation of the approved type and a copy of the EC

type-examination certificate.

3.2. The quality system must ensure compliance of the products [with the type as describcd in the

EC type-examination certificate and] with the requirements of the directive that apply to

them.

All the elements, requirements and provisions adopted by the manufacturer shall be

documented in a systematic and orderly manner in the form of written policies, procedures and

instructions. The quality system documentation must permit a consistent, interpretation of the

quality programmes, plan, manuals and records.

It must contain in particular and adequate description of

- the quality objectives and the organizational structure, responsibilities and powers of the

management with regard to product quality,

- the manufacturing, quality control and quality assurance techniques, processes and

systematic actions that will be used,

- the examinations and tests that will be carried out before, during and after manufacture,

and the frequency with which they will be carried out,

- the quality records, such as inspection reports and test data, calibration data, qualification

reports of the personnel concerned, etc.,

- the means to monitor the achievement of the required product quality and the effective

operation of the quality system.

3.3. The notified body must assess the quality system t o determine whether it satisfies the

requirements referred to in point 3.2. It presumes conformity with these requirements in

respect of quality systems that implement the relevant harmonized standard (*).

The auditing team must have at least one member with experience of evaluation in the product

technology concerned. The evaluation procedure must include an inspection visit to the

manufacturer's premises.

The decision must be notified to the manufactuer. The notification must contain the

conclusions of the examination and the reasoned assessment decision.

3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as

approved and t o uphold it so that it remains adequate and efficient.

The manufactuer or his authorized representative shall keep the notified body that has

approved the quality system informed of any intended updating of the quality system.

The notified body must evaluate the modifications proposed and decide whether the amended

quality system will still satisfy the requirements referred t o in paragraph 3.2 or whether a

re-assessment is required.

It must notify its decision to the manufacturer. The notification must contain the conclusions

of the examination and the reasoned assessment decision.

4 . Surveilhnce under the responsibility of thc notified body

4.1. The purpose of ssrveillance is to make sure that the manufacturer duly fulfils the obligations

arising out of the approved quality system.

4.2. The manufacturer must allow the notified body entrance for inspection purposes to the

locations of manufacture, inspection and testing, and storage and must provide it with all

necessary information, in particular

- the quality system documentation,

- the quality records, such as inspection reports and test data, calibration data, qualification

reports of the personnel concerned, etc.

(*) This harmonized standard will be EN 29 002, supplemer'ted, if necessary, to take into account the specific nature of the

products for which it is implemented.

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Official Journal of the European Communities

4.3. The notified body must periodically (") carry out audits to make sure that the manufacturer

maintains and applies the quality system and must provide an audit report t o the

manufacturer.

4.4. Additionally the notified body may pay unexpected visits to the manufacturer. During such

visits the notified body may carry out, or cause t o be carried w t , tests to verify that the quality

system is functioning correctly, if necessary. The notified body must provide the manufacturer

with a visit report and, if a test has taken place, with a test report.

5. l'he manufacturer must, for a period ending at least 10 years (")

after the last product has been

manufactured, keep at the disposal of the national authorities

- the documentation referred to in the second indent of point 3.1,

- the updating referred to in the second paragraph of point 3.4,

- the decisions and reports from the notified body which are referred t o in the final paragraph of

point 3.4, points 4.3 and 4.4.

6. Each notified body must give the other notified bodies the relevant information concerning the

quality system approvals issued and withdrawn (***).

Module E ( *

) (product quality assurance)

1. This module describes the procedure whereby the manufacturer who satisfies the obligations .of

point2 ensures and declares that the products concerned [are in conformity with the type as

described in the EC type-examination certificate and] satisfy the requirements of the directive that

apply to them. The manufacturer or his authorized representative established within the Community

must affix the CE mark to each product and draw up a written declaration of conformity. The CE

mark must be accompanied by the identification symbol of the notified body responsible for

surveillance as spxified in point 4.

2. The manufacturer:must operate an approved quality system for final product inspection and testing

as specified in paragraph 3 and must be subject to surveillance as specified in point 4.

3. Quality system

3.1. The manufacturer must lodge an application for assessment of his quality system for the

products concerned, with a notified body of his choice.

The application must include

- all relevant information for the product category envisaged,

- the quality system's documentation,

- if applicable, the technical documentation of the approved type and a copy of the EC

type-examination certificate.

3.2. Under the quality system, each product must be examined and appropriate tests as set out in

the relevant standard(s) referred to in Article 5 or equivalent tests shall be carried out in order

to ensure its conformity with the relevant requirements of the directive. All the elements,

requirements and provisions adopted by the manufacturer must be documented in a systematic

and orderly manner in the form ot written policies, procedures and instructions. This quality

system documentation must ensure a common understanding of the quality programmes, plans,

manuals and records.

It must contain in particular and adequate description of

- the quality objectives and the organizational structure, responsibilities and powers of the

management with regard to prodiia quality,

- the examinations and tests that will he carried out after manufacture,

- the means ro monitor the effective operation of the quality system,

- quality records, such as inspecrion reports and test data, calibration data, qualification

reports of the pcrsonnel concerned, etc.

( * ) I n the specific directives, the frequency may he Specified.

The specific direcrives may alter this period.

The specific dirccrives niay provide for different armngcments.

When this module is used without module H

- points2 and 3 of nindulcA must he added betrecn points I and 2 in order to incorporate :hc need for

technical docunicntation.

the words in square hrackets must bc deleted.

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Official Journal of the European Communities

3.3. The notified body must assess the quality system to determine whether ir satisfies the

requirements referred to in point 3.2. It presumes conformity with these requirements in

respect of quality systems that implement the relevant harmonized standard (*).

The auditing team must have at least one member experienced as an assessor in the product

technology concerned. The assessment procedure must include an assessment visit to the

manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the

conclusions of the examination and the reasoned assessment decision.

3.4. The manufacturer must undertake to discharge the obligations arising from the quality system

as approved and to maintain it in an appropriate and efficient manner.

The manufacturer or his authorized representative must keep the notified body which has

approved the quality system informed of any intended updating of the quality system.

The notified body must evaluate the modifications proposed and decide whether the modified

quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a

re-assessment is required.

It must notify its decision to the manufacturer. The notification must contain the conclusions

of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

4.1. The purpose of surveillance is t o make sure that the manufacturer duly fulfils the obligations

arising out of the approved quality system.

4.2. The manufacturer must allow the notified body entrance for inspection purposes to the

locations of inspection, testing and storage and shall provide it with all necessary information,

in particular

- the quality system documentation,

- the technical documentation,

- the quality records, such as inspection reports and test data, calibration data, qualification

reports of the personnel concerned, etc.

4.3. The notified body must periodically (")

carry out audits to ensure that the manufacturer

maintains and applies the quality system and must provide an audit report to the

manufacturer.

4.4. Additionally, the notified body may pay unexpected visits to the manufacturer. At the time of

such visits, the notified body may carry out tests or have them carried out in order t o check the

proper functioning of the quality system where necessary; it must provide the manufacturer

with a visit report and, if a test has been carried out, with a test report.

5 . The manufacturer must, for a period ending at least 10 years ( * * * ) after the last product has been

manufactured, keep at the disposal of the national authorities

- the documenration referred t o in the third indent of point 3.1,

- the updating referred to in the second paragraph of point 3.4,

- the decisions and reports from the notified body which are referred to in the final paragraph of

point 3.4, points 4.3 and 4.4.

6. Each notified body must forward to the other notified bodies the relevant information concerning

the quality system approvals issued and withdrawn ( * ***).

Module F (**'**) (product verification)

1. This module describes the procedure whereby a manufacturer or his authorized representative

established within the Community checks and attests that the products subject to the provisions of

point 3 [are in conformity with the type as described in the EC-type examination certificate and]

satisfy the requirements of the directive that apply 1.0 them.

(*) This harmonized standard will be EN 29 003, supplemented if necessary to allow for the specific features of the

products for which it is implemented.

The intervals between audits may be specified in the sycific directives.

The specific directives may alter this period.

The specific directives may provide for different arrangements.

Where this module is used without module B

- it must be supplemented by points 2 and 3 of module A (between points 1 and 2), so as to introduce the need

for technical docurnentation,

- the next in square brackets must be deleted.

No L22Ol35

Official Journal of the European Communities

2. The manufacturer must take all measures necessary in order that the manufacturing process ensures

conformity of the products [with the type as described in the EC type-examination certificate and]

with the requirements of the directive that apply to them. He shall affix the CE marking to each

product and shall draw up a declaration of conformity.

3. The notified body must carry out the appropriate examinations and tests in order to check the

conformity of the product with the requirements of the directive either by examination and testing of

every product as specified in point 4 or by examination and testing of products on a qtatistical basis,

as specified in point 5, at the choice of the manufacturer (*).

The manufacturer or his authorized representative must keep .a copy of the declaration of

3a.

conformity for a period ending at least 10 years (")

after the last product has been

manufactured.

4. Verification by examination and testing of every product

4.1. All products must be individually examined and appropriate tests as set out in the relevant

standard(s) referred t o in Article 5 or equivalent tests shall be carried out in order to verify

their conformity with [the type as described in the EC-type examination certificate and] the

requirements of the directive that apply to them.

4.2. The notified body must affix or cause t o be affixed, its identification symbol to each approved

product and draw up a written certificate of conformity relating to the tests carried out.

4.3. The manufacturer or his authorized representative must ensure that he is able to supply the

notified body's certificates of conformity on request.

5 . Stutistical verification

5.1. The manufacturer must present his products in the form of homogeneous lots and shall take all

measures necessary in order that the manufacturing process ensures the homogeneity of each

lot produced,

5.2. All products must be available for Verification in the form of homogeneous lots. A random

sample shall be drawn from each lot. Products in a sample shall be individually examined and

appropriate tests as set out in the relevant standard(s) referred to in Article 5, or equivalent

tests, shall be carried .out to ensure their conformity with the requirements of the directive

which apply to them and to determine whether the lot is accepted or rejected.

5.3. The statistical procedure. must use the following elements

(Relevant elements must be specified here such as, for example, the statistical method to be

applied, the sampling plan with its operational characteristics, etc.)

5.4. In the case of accepted lots, the notified body must affix, or cause to be affixed, its

identification symbol to each product and shall draw up a written certificate of conformity

relating to the tests carried out. All products in the lot may be put on the market except those

products from the sample which were found not to be in conformity.

If a lot is rejected, the notified body or the competent authority must take appropriate

measures to prevent the putting on the market of that lot. In the event of frequent rejection of

lots the notified body may suspend the statistical verification.

The manufacturer may, under the responsibility of the notified body, affix the latter's

identification symbol during the manufacturing process.

5.5. The manufacturer or his authorized representative must ensure that he is able to supply the

notified hody's certificates of conformity on request.

Module G (unit verification)

1. This module describes the procedure whereby the manufacturer ensures and declares that the

product concerned, which has been issued with the certificate referred to in point 2, conforms to the

requirements of the directive that apply to it. The manufacturer or his authorized representative

established within the Community must affix the CE marking to the product and draw up a

declaration of conformity.

2. The notified body niust examine the individual product and carry o C t the appropriate tests as set out

in the relevant standard(s) referred to in Article 5, or equivalent tests, to ensure its conformity with

the relevant requirements of the directive.

( * ) The manufacrurcr's discreticin nlay be limited in the specific directives.

The specific directives m3y alter this period.

B

Official Journal of the European Communities

The notified body must affix, or cause t o be affixed, its identification number on the approved

product and shall draw up a certificate of conformity concerning the tests carried out.

3. The .aim of the technical documentation is to enable conformity with the requirements of the

directive to be assessed and the design, manufacture and operation of the product to be

understood (*).

Module H (full quality assurance)

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of

paragraph 2 ensures and declares that the products concerned satisfy the requirements of the

directive that apply to them. The manufacturer or his authorized representative established within

the Community must affix the CE marking to each product and draw up a written declaration of

conformity. The CE marking must be accompanied by the identification symbol of the notified body

responsible for the surveillance as specified in point 4.

2. The manufacturer must operate an approved quality system for design, manufacture and final

product inspection and testing as specified in point 3 and shall be subject to surveillance as specified

in point 4.

3. Quality system

3.1. The manufacturer must lodge an application for assessment of his quality system with a

notified body.

The application must include

- all relevant information for the product category envisaged,

- the quality system’s documentation.

3.2. The quality system must ensure compliance of the products with the requirements of the

directive that apply to them.

All the elements, requirements and provisions adopted by the manufacturer must be

documented in a systematic and orderly manner in the form of written policies, procedures and

instructions. This quality system documentation shall ensure a common understanding of the

quality policies and procedures such as quality programmes, plans, manuals and records.

It must contain in particular an adequate description of

- the quality objectives and the organizational structure, responsibilities and powers of the

management with regard to design and product quality,

- the technical design specifications, including standards, that will be applied and, where the

standards referred to in Article 5 will not be applied in full, the means that will be used t o

ensure that the essential requirements of the directive that apply to the products will be

met,

- the design control and design verification techniques, processes and systematic actions that

will be used when designing the products pertaining to the product category covered,

- the corresponding manufacturing, quality control and quality assurance techniques,

processes and systematic actions that will be used,

- the examinations and tests that will be carried out before, during and after manufacture,

and the frequency with which they will be carried out,

- the quality records, such as inspection reports and test data, calibration data, qualification

reports of the personnel concerned, etc.,

- the means to monitor the achievement of the required design and product quality and the

effective operation of the quality system.

(*) The content of rhe technical documentation shall be laid down directive by directive in accordance with the products

concerned. As an example, the documentation shall contain so far as relevant for assessment

- a general description of the product,

- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of sald drawings and schcmes and the operation of

the product,

- a list of the standards referred to in Article 5 , applied i:i full o r In part, and descriptions of the solutions adopted to

meet the essential requirements of the directive where the standards referred to in Article 5 have not been

applied,

- results of design calculations made, examinations carried out, etc.,

- test reports.

No L 220137

Official Journal of the European Communities

3.3. The notified body must assess the quality system to determine whether it satisfies the

requirements referred to in point 3.2. It shall presume compliance with these requirements in

respect of quality systems that implement the relevant harmonized standard (*).

The auditing team must have ar least one member experienced as an assessor in the product

technology concerned. The evaluation procedure shall include an assessment visit to the

manufacturer's premises.

The decision must be notified t o the manufacturer. The notification must contain the

conclusions of the examination and the reasoned assessment decision.

3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as

approved and to uphold it so that it remains adequate and efficient.

The manufacturer or his authorized representative must keep the notified body that has

approved the quality system informed of any intended updating of the quality system.

The notified body must evaluate the modifications proposed and decide whether the amended

quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a

re-assessment is required.

It must notify its decision to the manufacturer. The notification shall contain the conclusions of

the examination and the reasoned assessment decision.

4. EC surveillance under the responsibility of the notified body

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations

arising out of the approved quality system.

4.2. The manufacturer must allow the notified body entrance for inspection purposes to the

locations of dcsign, manufacture, inspection and testing, and storage, and shall provide it with

all necessary information, in particular

- the quality system documentation,

- the quality records as foreseen by the design part of the quality system, such as results of

analyses, calculations, tests, etc.,

- the quality records as foreseen by the manufacturing part of the quality system, such as

inspection reports and test data, calibration data, qualification reports of the personnel

concerned, etc.

4.3. The notified body must periodically (") carry out audits to make sure-that the manufacturer

maintains and applies the quality system and shall provide an audit report to the

manufacturer.

4.4. Additionally the notified body maypay unexpected visits to the manufacturer. At the time of

such visits, the notified body may carry out tests or have them carried out in order to check the

proper functioning of the quality system where necessary; it must provide the manufacturer

with a visit report and, if a test has been caried out, with a test report.

5. The manufacturer must, for a period ending at least 10 years ( * * * ) after the last product has been

manufactured, keep at the disposal of the national authorities

- the documentation referred to in rhe second indent of the second subparagraph of point 3.1,

- the updating referred to in the second subparagraph of point 3.4,

- the decisions and reports from the notified body which are referred to in the final subparagraph

of point 3.4, points 4.3 and 4.4.

6. Each notified body must forward to the other notified bodies the relevant information concerning

the quality system approvals issued and withdrawn ( * ').

( * ) This harmonized standard shall be EN 29 001, completed if necessary to take into consideration the specificity of

the products fo: which i t is implemented.

(") In the specific directives, the frequepcy may be specified.

( ' * * ) The specific directives may alter this period.

The specific directives niay provide for different arrangements.

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Official Journal of the European Communities

.

Possible supplementary requirements

Design examination

1. The manufacturer must lodge an application for examination of the design with a single notified

body.

2.. The application must enable the design, manufacture and operation of the product to be

understood, and shall enable conformity with the requirements of the directive t o be assessed.

It must include

- the technical design specifications, including standards, that have been applied,

- the necessary supporting evidence for their adequacy, in particular where the standards

referred to in Article 5 have not been applied in full. This supporting evidence must include

the results of tests carried out by the appropriate laboratory of the manufacturer o r on his

behalf.

3. The notified body must examine the application and where the design meets the provisions of

the directive that apply to it must issue an EC design examination certificate t o the applicant.

The certificate shall contain the conclusions of the examination, conditions for its validity, the

necessary data for identification of the approved design and, if relevant, a description of the

product's functioning.

4. The applicant must keep the notified body that has issued the EC design examination certificate

informed of any modification to the approved design. Modifications to the approved design

must receive additional approval from the notified body that issued the EC design examination

certificate where such changes m a y affect the conformity with the essential requirements of the

directive or the prescribed conditions for use of the product. This additional approval is given in

the form of an addition to the original EC design examination certificate.

5. The notified bodies must forward to the other notified bodies the relevant information

concerning

- the EC design examination certificates and additions issued,

- the EC design approvals and additional approvals withdrawn (*).

(') The specifir direcrives may provide for differenr arrangements.

approved quality

surveillance of the

approved QS for

Issues EC design

of the design ( I )

for

production and

system (QS)

EN 29001

CE marking

- Operates an

- Operates an

certificate ( I )

examination

surveillance

- Carries out

Carries out

Affixes the

K. (full quality

conformity

conformity

Notified body

Notified body

of the QS

Manufacturer

Manufacturer

sssurance)

Declares

- Verifies

testing

design

QS

-

-

-

-

- Submits technical

Z. (unit verification)

- Issues certificate

Submits product

documentation

of conformity

with essential

requirements

CE marking

conformity

- Affixes the

conformity

Notified body

Manufacturer

Manufacturer

- Declares

- Verifies

-

CONFORMITY ASSESSMENT PROCEDURES IN COMMUNITY LEGISLATION

approved type, or

- Issues certificate

conformity with

at conformity

with essential

requirements

CE marking

Affixes the

verification)

conformity

Notified body

,Manufacturer

I

I

I

- Declares

F. (product

- Verifies

-

approved type, or

- Approves the QS

approved quality

conformity with

for

inspection and

E. (producr quality

system (QS)

EN 29003

requirements

CE marking

- Operates an

surveillance

- Carries out

to essential

- Affixes the

Notified body

of the QS

Manufacturer

assurance)

- Ascertains conformity with essential requirements

- Declares

I

I

I

testing

B. (type examination)

- Issues EC type-exarnination certificate

Manufacturer submits to notified body

D, (production quality

.

- Approves the QS

approved quality

conformity with

system (QS) for

- Carries out tests, if necessary

production and

approved type

EN 29002

CE marking

- Operates an

surveillance

- Carries out

- Technical documentation

Affixes the

Stipplementary requirements which may be used in specific Directives.

Notified body

Manufacturer

of the QS

assurance)

I

I I

- Declares

I

testing

-

Notified body

- Type

- Tests on specific

conformity with

- Product checks

approved type

aspects of the

C. (conformity to

CE marking

product (I)

intervals ( I )

- Affixes the

Notified body

at random

Manufacturer

- Declares

type)

Tests on specific

conformity with

- Product checks

A. (Internal control

documentation at

aspects of the

of production)

requiremcnts

CE marking

Keeps technic:il

Intervention of

the disposal of

- Affixes the

intervals ( I )

Notified hody

at random

Manufacturer

product ( I )

,Manufacturer

notified body

Declares

essential

authorities

narional

-

-

Aa

Aa

A.

(I)

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